Expired Study
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North Miami Beach, Florida 33162


Purpose:

The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.


Study summary:

Trial Features: - Medical device (Non-drug option) - Most patients can remain on current treatment regimen throughout the study Components of the Study: - Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments - Physical exams, laboratory tests and disease assessments conducted at no charge to the patient - 2:1 Randomization (treatment:sham) - Open-Label extension offered to eligible patients


Criteria:

Key Inclusion Criteria: - Moderate to severe Crohn's disease - Adequate peripheral venous access - Agree to participate in the required follow-up visits - Able to complete a diary - Signed written informed consent document and authorization for use of protected health information Key Exclusion Criteria: - Extremely severe Crohn's disease - Known obstructive symptoms within the past 3 months - Presence of toxic megacolon - Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks - Total colectomy, ileostomy, stoma or 100 cm of resected small bowel - Requiring in-patient hospitalization - A history of allergic reaction to heparin or heparin-induced thrombocytopenia - A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures - A history of severe cardiovascular or peripheral arterial diseases - A history of cerebral vascular diseases - Liver diseases - Renal insufficiency - Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment - Any hypercoagulable disorder - Known infection with Hepatitis B or C, or HIV - Severe anemia - Leukopenia or granulocytopenia - Evidence of current systemic infection - Malignancy - Pregnant, lactating or planning to become pregnant during the course of the investigational study - Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic


NCT ID:

NCT00162942


Primary Contact:

Study Director
Yosuke Komatsu, MD, PhD
Otsuka America Pharmaceutical


Backup Contact:

N/A


Location Contact:

North Miami Beach, Florida 33162
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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